Impact of a Bridge Device on the Loop Ileostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-10

Study Completion Date

2023-10-02

Brief Summary

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During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue.

Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.

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Detailed Description

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Conditions

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Elective Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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no bridge device

After the ileostomy creation, no bridge device was placed.

Group Type EXPERIMENTAL

no bridge device

Intervention Type DEVICE

bridge device

A bridge device was placed after the stoma creation.

Group Type ACTIVE_COMPARATOR

bridge device

Intervention Type DEVICE

Interventions

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bridge device

Intervention Type DEVICE

no bridge device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
* requiring elective surgery with an ileostomy
* patient having given his consent before the enrollment

Exclusion Criteria

* patient with early closure of the stoma (within 10 days after the colorectal surgery)
* long term corticoids
* emergency surgery
* history of stoma in the side of the stoma placement planned for the study
* BMI \>50
* No signature of the consent to participate in the study
* Physical or mental state not allowing participation in the study
* Contraindication to surgery
* ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \<48h
* Pregnancy or breastfeeding
* Patient under guardianship or guardianship or patient deprived of liberty by a judicial or administrative decision (in accordance with articles L1121-6 and L1121-8 of the Public Health Code)
* Minor patient
* Patient without social protection

* no anastomosis
* no ileostomy
* Spontaneous stomal retraction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No